Intraductal radiofrequency ablation for unresectable malignant distal biliary obstruction: a randomised controlled clinical trial

Abstract

BACKGROUND: pancreatic cancer and cholangiocarcinoma are malignant tumors with an increasing incidence and generally a poor prognosis. They are the main causes of malignant biliary obstruction. Patients typically remain asymptomatic until the disease is significantly advanced with no possibilities of surgical resection. Endoscopic placement of biliary stents to relieve jaundice is the main palliative treatment, no local treatment is currently available. Endoscopic biliary radiofrequency ablation reduces the tumoral burden and has been reported to prolong stent patency, which may be beneficial in improving patient survival. Moreover, it has shown to have an adequate safety profile in previous studies. Nevertheless, available evidence is still insufficient as most of the data come from retrospective series, with a limited number of patients and uncontrolled studies. OBJECTIVES: the aim of this study is to assess whether the application of radiofrequency combined with stent placement in unresectable malignant distal biliary obstructions increases survival rate in comparison to stent placement alone. When it comes to secondary objectives, quality of life during the follow-up period will be assessed, as well as stent patency and number of hospitalizations.

DESIGN AND SETTING: this study is designed as a multicentric, randomized, controlled, single- blind, interventional clinical trial, performed in Hospital Universitari Doctor Josep Trueta and

Hospital Universitari Germans Trias i Pujol. PARTICIPANTS: adult patients with a histological confirmed pancreatic cancer or cholangiocarcinoma, presenting with an unresectable malignant distal biliary obstruction. METHODS: 118 patients will be recruited consecutively in Hospital Universitari Doctor Josep Trueta and Hospital Universitari Germans Trias i Pujol. Patients will be randomly assigned into two treatment groups: radiofrequency ablation plus stent placement (intervention group) or stent placement alone (control group). Participants will be followed during a two-year period in order to assess survival rates, stent patency, number of hospitalizations and quality of life